In October 2020 we first learned about a “new” drug safety issue for Ocaliva — although it apparently has been on the FDA’s radar since at least May 2020. It seems a possible Ocaliva liver-related side effects risk has attracted scrutiny, and there is an Ocaliva liver safety FDA evaluation underway.
It was this October 9, 2020, Endpoints News article, “In another blow to Intercept, the FDA is investigating Ocaliva for potential risk of liver disorder”, which brought to light an Ocaliva liver safety FDA evaluation. It was further reported in this article that a spokesman for Intercept, the pharmaceutical company responsible for Ocaliva, said he anticipates the current FDA safety investigation would take about 12 months.
Ocaliva (obeticholic acid) was approved by the FDA in 2016 for the treatment of a rare chronic liver disease, primary biliary cholangitis (PBC). Specifically, Ocaliva is FDA-approved for use in combination with ursodeoxycholic acid (UDCA) in adult PBC patients with an inadequate response to UDCA, or as monotherapy in adult PBC patients unable to tolerate UDCA.
Back in 2017 and 2018, the FDA warned that Ocaliva was being incorrectly dosed daily instead of weekly in patients with PBC, and thereby increasing the risk of serious liver injury. For the details of this earlier drug safety issue for Ocaliva, see “FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease”.
Given that the current Ocaliva liver safety FDA evaluation began about five months ago, we can look for the results of this FDA in or about May 2021.
Of course, we will continue to monitor the safety of Ocaliva going forward.[Read article in full at original source]